NCT04113382 · Ferring Pharmaceuticals
Study Assessing CLENPIQ As Bowel Preparation for Pediatric Colonoscopy
(PICCOLO)
What this study is about
Bowel preparation for pediatric colonoscopy.
View original scientific description
Bowel preparation for pediatric colonoscopy.
Interventions
DRUG
CLENPIQ
CLENPIQ consists of sodium picosulfate 10.0 mg + magnesium oxide 3.5 g + citric acid, anhydrous 12.0 g. Supplied as a pre-mixed, ready-to-drink oral solution in two bottles, each containing 160 mL.
DRUG
MIRALAX
MIRALAX powder for oral solution, supplied in a 8.3 oz multi-dose bottle containing 238 g of laxative powder (polyethylene glycol \[PEG\] 3350). MIRALAX is mixed with non-carbonated, clear beverage, or water and consumed at specified intervals until the total required dose.
DRUG
SENNA
SENNA Liquid (chocolate flavor) is an oral solution to be taken according to body weight (8.8 mg for 10-22 kg, 17.6 mg for 22-34 kg and 26.4 mg for \>34 kg) prior to MIRALAX.
Primary outcome measures
Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale
Time frame: On the day of colonoscopy (Day 1)
The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female, aged 12 months to \<9 years being scheduled to undergo elective colonoscopy.
- Weight ≥10 kg (≥22 lbs).
- Participants must have had regular spontaneous bowel movements (SBM) weekly for 1 month prior to the colonoscopy.
- Written informed consent (by parent(s)/ caregiver(s)/ guardian(s)) and assent (if applicable) obtained at screening.
Exclusion criteria
- History of significant liver, cardiovascular, or renal disease (including recent or ongoing oliguria).
- Acute surgical abdominal conditions (e.g., acute obstruction or perforation) during the screening period.
- Concern for obstipation or fecal impaction.
- Severe acute inflammatory bowel disease (IBD) defined as subjects with a Pediatric Ulcerative Colitis Activity Index (PUCAI) score \>65 or a Short Pediatric Crohn's Disease Activity Index (short PCDAI) score \>40, at the time of screening, or development of severe IBD between (Visit 1) and investigational medicinal product (IMP) dispensation (Visit 2).
- Any prior colorectal surgery, excluding appendectomy and polyp removal.
- History of colon disease (e.g., Hirschsprung disease, volvulus, idiopathic pseudo-obstruction, or hypomotility syndrome).
- History of or ongoing intestinal ulceration, toxic megacolon or other toxic colitis.
- History of upper gastrointestinal disorder (e.g., active ulcer, pyloric stenosis or other cause of gastric retention, gastroparesis, or ileus).
- History of upper gastrointestinal surgery (e.g., gastric resection or gastric bypass), excluding cholecystectomy.
- Chronic or persistent, severe nausea or vomiting during the screening period.
- Moderate to severe dehydration during the screening period.
- Prior history of epileptic reaction, convulsions, or seizures.
- Any clinically relevant neurological events with or without association with hyponatremia during the screening period.
- Serum creatinine, estimated glomerular filtration rate (eGFR), potassium, or sodium outside normal limits during the screening period.
- Hypermagnesemia during the screening period.
- Use of the following prohibited medication: lithium (within 48 hours prior to procedure), laxatives (within 24 hours prior to procedure), drugs that in the opinion of the investigator are causing constipation in the participant (within 48 hours prior to procedure), antidiarrheal drugs (within 72 hours prior to procedure), or oral iron preparations (within 1 week prior to procedure).
- Participation in an interventional investigational trial requiring administration of an investigational drug within 30 days prior to receiving trial medication (or within 60 days for investigational drugs with an elimination half-life \>15 days).
- Any clinically relevant abnormal findings in medical history, physical examination, vital signs, electrocardiogram (ECG), clinical chemistry, hematology, coagulation, or urinalysis at screening which in the opinion of the investigator(s), might put the participant at risk because of his/her participation in the trial.
- Hypersensitivity to any of the ingredients of the trial medications.
- Inability to comply with the dietary restrictions in the trial or the fluid requirements before and after investigational medicinal product (IMP) administration.
Where
- Mobile, Alabama
- San Diego, California
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations